An aneurysm is a vascular defect indicated generally by an expansion and weakening of the wall of an artery of a patient. Aneurysms can develop at various sites within a patient's body. Thoracic aortic aneurysms (TAAs) or abdominal aortic aneurysms (AAAs) are manifested by an expansion and weakening of the aorta which is a serious and life threatening condition for which intervention is generally indicated. Existing methods of treating aneurysms include invasive surgical procedures with graft replacement of the affected vessel or body lumen or reinforcement of the vessel with a graft.
Surgical procedures to treat aortic aneurysms can have relatively high morbidity and mortality rates due to the risk factors inherent to surgical repair of this disease as well as long hospital stays and painful recoveries. This is especially true for surgical repair of TAAs, which is generally regarded as involving higher risk and more difficulty when compared to surgical repair of AAAs. An example of a surgical procedure involving repair of an AAA is described in a book titled Surgical Treatment of Aortic Aneurysms by Denton A. Cooley, M. D., published in 1986 by W. B. Saunders Company.
Due to the inherent risks and complexities of surgical repair of aortic aneurysms, minimally invasive endovascular repair has become a widely-used alternative therapy, most notably in treating AAAs. Early work in this field is exemplified by Lawrence, Jr. et al. in “Percutaneous Endovascular Graft: Experimental Evaluation”, Radiology (May 1987) and by Mirich et al. in “Percutaneously Placed Endovascular Grafts for Aortic Aneurysms: Feasibility Study,” Radiology (March 1989).
When deploying endoluminal prosthesis type devices by catheter or other suitable instrument, it may be advantageous to have a flexible and low profile endoluminal prosthesis such as a stent graft and delivery system for passage through the various guiding catheters as well as the patient's sometimes tortuous anatomy. Many of the existing endovascular devices and methods for treatment of aneurysms, while representing significant advancement over previous devices and methods, use systems having relatively large transverse profiles, often up to 24 French. Also, such existing systems have greater than desired lateral stiffness, which can complicate the delivery process, particularly for use in treatment of vascular defect sites that include a high degree of curvature or angulation. Even with more flexible low profile delivery systems, deployment of endovascular prostheses in highly angulated and curved vessels may be problematic due to difficulties with visualization or imaging of the orientation of the prostheses during the deployment process. Achieving a proper seal between an outer surface of an endovascular prosthesis and an inner surface of a vessel being treated after deployment of the endovascular prosthesis may also be challenging in some instances. As such, minimally invasive endovascular treatment of aneurysms may not be available for many patients that would benefit from such a procedure and can be more difficult to carry out for those patients for whom the procedure is indicated.
What have been needed are endoluminal prostheses and suitable delivery catheters that are adaptable to a wide range of patient anatomies and that can be safely and reliably deployed using a flexible low profile system.